Regulatory Affairs Manager

This is a fully remote position, open to applicants in Germany.

📋 Description

• Take charge of regulatory decision-making for designated clinical trials and programs.

• Convert indication-level regulatory strategies into practical trial-level regulatory plans and execution strategies.

• Offer strategic regulatory insights, guidance, and technical expertise to both internal and external stakeholders.

• Keep abreast of legislation, regulatory requirements, guidelines, and emerging developments in the regulatory landscape.

• Act as a subject-matter expert in regulatory affairs across global, regional, and country-specific requirements.

• Lead cross-functional clinical trial teams to implement regulatory strategies and meet study and program goals.

• Collaborate with Clinical Operations and other departments to incorporate regulatory requirements, dependencies, risks, and timelines into operational plans.

• Define regulatory priorities and accountabilities within clinical trial teams.

• Facilitate discussions around regulatory challenges, ensuring decisions are documented, communicated, and executed.

• Highlight significant regulatory risks and strategic issues while ensuring follow-through and resolution.

• Participate in launch meetings, project reviews, governance discussions, and project team meetings.

• Formulate global regulatory strategies and prepare submissions for Regulatory Authorities and Ethics Committees.

• Provide senior-level review and strategic advice for regional regulatory submissions.

• Guarantee that regulatory deliverables are accurate, consistent, compliant, and timely.

• Ensure adherence to organizational and regulatory SOPs, WPDs, policies, and procedures.

• Maintain quality performance across assigned and managed projects.

• Oversee project budgets and forecasting activities.

• Identify out-of-scope activities and assist with contract modifications.

• Foster effective client relationships and support timely regulatory decisions.

• Work with Business Development on pricing and new business opportunities, client presentations, and proposals.

• Provide matrix/project leadership, mentoring, training, and support to junior team members.

⛳️ Requirements

• Bachelor’s degree or an equivalent relevant academic/vocational qualification.

• Generally requires 9+ years of relevant experience.

• A combination of appropriate education, training, and directly related experience may be considered.

• Excellent written and verbal communication skills in English, along with local language proficiency where applicable.

• Capacity to make and own regulatory decisions.

• Strong cross-functional leadership and influencing abilities in a matrix environment.

• Robust operational mindset with the capability to convert regulatory strategy into actionable plans.

• Skilled at identifying regulatory and operational risks, evaluating options, recommending actions, and driving resolution.

• Experience with Platform Protocols and Integrated Protocol Designs is highly desirable.

• Exceptional interpersonal and stakeholder management skills.

• Strong negotiation and conflict resolution capabilities.

• Ability to work independently and exercise sound judgment.

• Comprehensive understanding of global, regional, and national regulatory requirements and procedures for clinical trial authorization, licensing, registration, and lifecycle management.

• Expert knowledge of ICH guidelines and other relevant global regulatory standards.

• Advanced expertise in one or more regulatory specialty areas such as clinical, preclinical, CMC, publishing, or related fields.

• Strong understanding of medical terminology, statistical concepts, and pertinent scientific and regulatory guidelines.

• Excellent analytical, investigative, decision-making, and problem-solving abilities.

• Strong organizational, planning, and time management skills.

• Exceptional attention to detail, quality, editorial review, and proofreading abilities.

• Good understanding of project budgeting and forecasting.

• Advanced proficiency in Microsoft Word, Excel, and PowerPoint.

• Willingness to learn and adopt new technologies.

🏝️ Benefits

• Fully remote work arrangement.

• Standard Monday–Friday work schedule.

• Preferential consideration for severely disabled applicants who meet the same qualifications.

• Opportunities for occasional domestic and international travel.